and Human Services (HHS)
EXPIRED
DEVELOPING CENTERS ON INTERVENTIONS FOR THE PREVENTION OF SUICIDE (DCIPS) RELEASE DATE: August 6, 2003 RFA Number: RFA-MH-04-003 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.242, 93.279, 93.273 LETTER OF INTENT RECEIPT DATE: October 17, 2003 APPLICATION RECEIPT DATE: November 18, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of the RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA), and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) encourages investigator-initiated research grant applications to establish Developing Research Centers on Interventions for the Prevention of Suicide (DCIPS). The purpose of this initiative is to establish core support for building research infrastructure for the study of preventive and treatment interventions for suicidality (severe ideation, attempts, deaths) related to mental health, substance use disorders (SUDs) and alcohol use disorders (AUDs). This RFA provides a grant mechanism to support an early phase of infrastructure building to be utilized by qualified institutions with active research programs but without the existing capacity to mount the extensive and highly integrated research effort expected of an advanced center (e.g., Advanced Centers for Interventions and Services Research, PAR-01-089 http://grants.nih.gov/grants/guide/pa-files/PAR-01-089.html). The intent of this RFA is to provide the initial 5-year infrastructure support needed to build an integrated program that could qualify for full or advanced center mechanisms that may be available from participating Institutes in the future. RESEARCH OBJECTIVES BACKGROUND In 2000, 29,350 persons died by suicide in the United States. Suicide deaths outnumber homicide deaths by 5 to 3. Suicide was the third leading cause of death for 10-24 year olds, and the eighth leading cause of death for males. Vital statistics indicate that suicide rates vary dramatically by demographic characteristics. Males die by suicide more frequently than females by a ratio of 4 to 1. Older white males have the highest suicide rate, followed by young American Indian and Native Alaska males. In contrast, older African American females have one of the lowest rates. Married persons have lower rates than unmarried persons. Rural suicide rates exceed those in urban areas, and state rates vary by region, with Western mountain states having the highest suicide rates in the Nation. The health conditions most consistently associated with suicide are mental illness, SUDs and AUDs, affecting up to 90% of all people who die by suicide. Family history of suicide, and an individual's prior history of suicide attempts and serious suicidal ideation are also significantly associated with later suicide death. However, despite the strong associations among suicide death and mental illness and SUDs and AUDs, only a small proportion of persons with these disorders actually die by suicide. Suicide attempts and serious suicide ideation, each more frequent than suicide deaths, also carry a substantial health burden. For the year 2000, estimates of the number of persons treated annually for self-inflicted injuries, most which are suicide attempts, ranges from 264,000 to 864,000. About half the number of persons who attempt are estimated not to seek treatment. Since they are not included in treatment-setting based surveillance estimates, these attempt rates may be underestimated by 50%. In addition to the burden from physical harm consequent to the behavior, suicide attempts are associated with increased risk of later suicide death by 40-fold. Severe ideation has also been found to be associated with later suicide death, as well as significant morbidity. In 2002, the IOM released the report, Reducing Suicide: A National Imperative (see http://www.nimh.nih.gov/research/suicideiom.cfm). Noting suicide's high mortality and morbidity rates, the report recommended increasing the research infrastructure for suicide studies through a center mechanism. Infrastructure supporting tissue banks and registries, as well as community-based approaches to understanding social forces such as cultural risk and protective factors, were among the specific issues highlighted. While much has been documented about suicide risk factors, particularly mental illness, SUDs and AUDs, there has been little rigorous evaluation of the effect of evidence-based or empirically-validated interventions on suicidality or suicide risk. There is a small but growing area of intervention research that tests targeted treatments of suicidal behavior per se, but much more research is needed to determine efficacy of those approaches along with treatments for the common conditions that accompany suicidality. The IOM report also highlighted the need for evaluation of current community and regional suicide prevention efforts. Many schools, communities, tribes, and states have suicide prevention programs in place but lack resources or adequate expertise to evaluate their effectiveness. The report noted that suicide victims were more likely to have sought treatment in primary care rather than in mental health, alcohol, or substance abuse treatment systems, raising the challenge for how best to improve detection and treatment of suicidality in primary care. The IOM report highlighted how Centers can also provide further training opportunities to expand the number of researchers with expertise in all areas of suicide research. AIMS The prevention and intervention research that is needed to reduce morbidity related to suicidality as well as suicide deaths requires the adoption of novel methodological and organizational approaches, building of new partnerships, and, in general, enlargement of research activities beyond the traditional boundaries of academic settings and specific academic departments. This RFA proposes to support an infrastructure mechanism to build capacity at qualified institutions to enable them to pursue a research agenda that contributes to effective suicide treatment and prevention. The goal for these centers is to: 1) build networks to conduct intervention/prevention trials and/or evaluate community practice and service systems, 2) foster interdisciplinary collaboration, 3) develop new research methods, 4) develop, pilot and test novel treatments for suicidal behavior, with particular emphasis on interventions translated from basic science and/or neuroscience, and 5) cultivate training opportunities for new and established investigators. PROGRAM SPECIFICATIONS Grants awarded under this RFA will provide financial support for two types of activities: (1) general development of research infrastructure and (2) funding of at least two specific "developing research projects." All the activities will be under the overall direction and supervision of the Principal Investigator, who will function as director of the Developing Center. The Principal Investigator should be an established independent intervention researcher in the area(s) of mental illness, SUDs and/or AUDs and will have a minimum time commitment of 30 percent to the Developing Center. All applications must have an Operations Core, Methods Development Core, and Principal Research Core. Development of Research Infrastructure It is expected that the applicants will have current research activities at their institution and will explain how research on suicidality, mental disorders, SUDs and/or AUDs can be expanded and enhanced by the support requested under this RFA. Particular emphasis should be given to how a Center would facilitate interdisciplinary collaboration that is not otherwise occurring, or is occurring only to a limited extent. The application should describe how the Center will expand research training opportunities for junior investigators or established investigators willing to focus their efforts on suicide prevention research. The direct support of training efforts (e.g., stipends), however, must be sought through other NIH training and career development grant mechanisms. Operations Core The DCIPS must have a clearly articulated Operations Core that should serve to integrate the scientific and infrastructure aims. This core includes administrative functions, data management and statistical analysis, dissemination activities, intervention trials operations if appropriate, and any specialized interdisciplinary components. The Operations Core should foster an environment of research excellence, support methodological innovation, facilitate multidisciplinary collaborations, coordinate efforts, and monitor progress according to an overall focused research agenda. As appropriate, these efforts should include the engagement of community stakeholders, such as family members of those who have died by suicide, individuals with mental illness and/or SUDs and/or AUDs and their families, mental health and substance abuse treatment providers, medical care providers, hospital emergency departments, community organizations and institutions (e.g., schools, group homes, and extended care facilities), state, county or tribal officials, public and private purchasers of care, and insurers and managed care organizations. The Operations Core should include a data management and statistical analysis component as well as an intervention trials operations component when relevant. These components may be located at a single institution or across multiple institutions. Depending on the research focus, other specialized components might be included in the Operations Core (e.g., economics component). Applicants should describe efforts for recruitment and retention of research participants and data collection activities within this core. The DCIPS may consist of several collaborating sites that are not all located in a single institution or geographic region. The collaboration of multiple institutions and settings to create a "virtual center" must be specified and explained in the Operations Core section so the feasibility of such arrangements can be evaluated. The Operations Core of the application should outline the scientific leadership for all anticipated research. It should describe an administrative structure that maximizes efficiency through program planning and monitoring, an infrastructure development and maintenance plan, opportunities for investigators to do integrative work, and plans for accountability. The Operations Core should also address knowledge and technology transfer if appropriate, and enhancing the availability of center accomplishments (e.g., data, methods, etc.) within and beyond the center. Methods Development Core Each application should describe a process for building a Methods Development Core. The purpose of this core function is to support the initial testing and feasibility of innovative approaches to research design, assessment methods, recruitment strategies, and analytic approaches needed to advance suicide prevention and intervention and research. For more specified and developed projects, applicants should seek funding through traditional mechanisms (R01, R21, R03). There are a large number of potential areas of research methods investigation that could be included in this core. The following are some examples of research areas that could fit in this core. These are not meant to be comprehensive, nor are the examples meant to be exclusive of other topics. A center might: o develop and evaluate ways to adapt suicide prevention or suicide assessment and treatment protocols previously used in academic clinical settings for use in community settings (e.g., creating "community friendly" protocols that maintain potency, and are acceptable to community treatment providers, by modifying existing efficacious approaches); o develop and evaluate ways to measure and monitor suicidality and its possible precursors (e.g., agitation, anxiety, disinhibition, akathisia) as potential side effects related to interventions; develop and test other possible surrogate markers for suicidal crises; develop protocols that improve surveillance of serious suicidality side effects and rescue efforts; o apply research methods that integrate qualitative and quantitative methods into intervention development to address understudied populations with particular risk and protective factors (e.g., persons in rural areas, run-away youth); o develop new designs for conducting trials and statistical techniques to analyze data that address low base-rate outcomes; o develop methods for engagement, recruitment, and retention of high risk research participants who typically do not engage in treatment follow-up; o develop methods that readily translate intervention outcomes to information relevant to community stakeholders such as payers and public policy makers (e.g., economic analyses of suicide deaths, attempts, and risk factors with regard to years of life lost, or morbidity impact such as disability and functional status); o improve suicide research studies through utilization of theory and methods from related fields (population approaches to preventing cardiovascular disease) or outside the health fields (e.g., decision analysis, marketing and engineering). o develop new approaches for the prevention of suicide through interdisciplinary collaboration, by translating findings from basic behavioral science and/or cognitive or affective neuroscience into clinical interventions Applicants are encouraged to focus on how this core will enhance the research activities chosen in the Principal Research Core (see below). Principal Research Core The DCIPS must have a clearly articulated plan to develop a set of scientific core functions that will enhance and expand capacity for suicide intervention and prevention research. Applicants should select a major focus for the research core and propose at least two projects to address it. The research area chosen should be the primary research focus of the center and all other cores should clearly relate to the efforts pursued in this core. A separate description must be provided for the Principal Research Core area, including potential research proposals in this area, summary descriptions of exploratory and developmental research projects, and how these proposals and projects will relate to and support one another as well as projects in other cores. Proposed projects are intended to provide preliminary data to be utilized in guiding the design of more definitive investigations. These projects are similar to the ones typically supported under developing grant mechanisms such as the R34 (e.g., http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html). Applicants should describe how the Operations and Methods Development Cores are integrated in the service of this Principal Research Core and related research projects. Examples of research topics of interest include, but are not limited to: o develop and test psychotropic medications to determine whether they are effective in reducing suicidality in randomized clinical trials; o evaluate the efficacy of various pharmacotherapies alone, and in combination with various behavioral therapies in the treatment of alcohol abusing and/or substance abusing suicidal patients, with and without co-occurring mental disorders; o develop, modify, and test behavioral treatments for drug and alcohol abusing individuals exhibiting suicidal behavior (see Behavioral Therapies Development Program Announcement: http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html) o identify factors influencing clinical efficacy of medications using human laboratory behavioral pharmacology paradigms; o identify interactions of medications to treat AUD, SUD, and mental illness as well as interactions with alcohol and other drugs to determine what is safe, effective treatment; o test measures of suicidality side effects and/or possible precursors or surrogate markers for various interventions for their utility in intervention trial safety efforts; o evaluate the efficacy of established and novel pharmacological agents for AUD and SUD patients with comorbid psychiatric disorders; o develop and test interventions for comorbid AUD, SUD, mental illness and suicidality, testing integrated and/or sequenced approaches (both pharmacologic and psychosocial) for various symptoms; o examine the potency of "usual care" interventions for AUDs, SUDS and mental illness in the community (e.g., day treatment, short-term hospitalization); o identify potential mediators and moderators of effective interventions associated with the individual, family, provider, health system, and community and cultural factors; examine mechanisms of action of behavioral treatments for comorbid alcohol and/or drug abuse and suicidality; o expand existing prevention and treatment programs for youth that may be focused on the reduction of substance use and/or alcohol use or aggressive behavior to include suicidality outcomes and the ethical and safety challenges involved in identifying imminent risk research participants; o while effective treatments for depressed, suicidal older adults can be delivered in primary care settings, efforts to improve uptake and maintenance of effective delivery models in community settings are needed; o test the effectiveness and utility of alternative methods or settings to assess suicide risk and deliver interventions (e.g., religious organizations, tele-health, and/or web-based media) and/or studies to improve delivery of interventions in traditionally underserved areas (e.g., rural and frontier areas); o develop and test interventions that safely and effectively increase general public awareness, or awareness among particular target groups at risk (e.g., parents of adolescents who have attempted suicide) of suicide and its risk factors; o develop techniques for the engagement, retention, and adherence of comorbid patients suffering from AUD, SUD and various psychiatric illnesses and suicidality. o adapt/refine existing interventions, or develop new interventions targeted to the specific needs of the varied demographic groups at risk for suicide (e.g., older white males, young American Indian and Alaska Native males), taking into account the power of cultural norms that may influence behaviors related to suicidality. Principal Research Cores should be integrated with Methods Development Cores to address critical suicide intervention and prevention research needs. The following are some examples of how a DCIPS could integrate Research Methods and Principal Methods Development Cores. A Center could propose, for example, as a primary aim, tests of efficacy of established and novel pharmacological agents for AUD and SUD patients with comorbid psychiatric disorders and suicidality. Combination and/or sequencing of pharmacological and psychosocial therapies would be explored. Assessment of possible interaction side effects of medications to treat AUD, SUD and mental illness as well as interactions with alcohol and/or other substances would be assessed. Pilot pharmacokinetic studies would also be implemented. Experts in combordity interventions, and pharmacokinetics are a part of the center research team, and a partnership with state substance abuse treatment programs involve patients and providers from that system. A Center could propose to focus on the development, efficacy testing, and community-based testing of innovative behavioral treatments, and/or combined behavioral and pharmacological treatments, for suicidal individuals with co- occurring AUD or SUD. Innovative behavioral treatments could be based upon findings from basic science, such as cognitive and affective neuroscience. The Center could propose Stage I, Stage II, and Stage III research activities (see Behavioral Therapies Development Program Announcement: http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html) A DCIPS could have a primary aim to develop methodologies to evaluate state/ community suicide prevention efforts; develop appropriate intermediate target outcomes (reduced injury, substance use, depressive symptom rates) for suicide prevention, and collaborate with and train state and community partners so that evaluation efforts can continue post-grant period. PIs would have expertise in community-based prevention, epidemiology and dissemination research, and would demonstrate the capability of engaging state entities such as mental health/ substance abuse treatment centers, and coordinate with state public health officials regarding CDC funded surveillance on morbidity or mortality outcomes (e.g., Emergency Department Ambulatory Surveys, State Fatality Reviews). A DCIPS could expand evidence-based treatments for suicidality across specific as well as comorbid disorders (AUDs, SUDs, major depression, schizophrenia, bipolar disorders), and consider common "active ingredients" of psychosocial interventions, as well as further refining the use of effective pharmacologic agents with putative anti-suicidality effects (e.g., lithium, clozapine) among adults. Collaboration with community-based primary care, mental health and substance abuse treatment centers ensures the representativeness of treatment samples, and efforts are made to train clinic staff as field trial providers. Testing effective treatments adapted for younger persons (adolescents) or older adults could be exploratory aims. Center personnel would include bioethicists able to collaborate on developing safe and ethical trial designs. A Center aim could be to develop and initially test novel interventions for known high-risk groups who do not intersect with traditional specialty mental health or AUD or SUD treatment service settings (older white males, adolescents/ young adults who are not in school, unemployed). Intervention approaches could include optimization of protective factors, reframing of the need for health care seeking to reduce "stress" and/or improve employment options, or harm reduction approaches. PIs have expertise in social and community psychology, violence and substance use prevention, health education, and partner with EAP staff, state unemployment offices, and/or juvenile detention settings. Specific Research Projects At least two developmental research projects must be described in the application with enough detail to allow appropriate peer-review of their scientific merit and methodological soundness. Due to the purposes of this RFA and its funding limitations, such projects are not expected to be major research proposals, able to test major experimental hypotheses in a definitive manner. Rather, such projects are intended to provide preliminary data to be utilized in guiding the design of future more definitive investigations. These projects are similar to the ones typically supported under developing grant mechanisms such as the R34 (e.g., http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html). The focus of these specific research projects will be relevant to the focus of the Principal Research Core that the applicant has chosen to include in the developing center. ORGANIZATION OF CENTERS A Developing Center on Interventions for the Prevention of Suicide (DCIPS) may be organized in a variety of ways and may include one institution or several. There is no single model for a DCIPS; the structure will depend upon the research questions and approaches selected to study them. One type of center could adopt a Clinical Research Organization type approach, providing administrative, management, and operational support to a large set of ongoing and planned suicide intervention and/or prevention studies in various community sites. Another type of center could adopt a decentralized, multi-site focus in which specialized activities are supported in different sites. A conceptual and theoretical rationale for the organizational structure should be discussed in the application. However, they must include the required cores outlined above. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Exploratory Center Grant award mechanism (P20). This mechanism supports planning for new programs, expansion or modification of existing resources, and feasibility studies to explore various approaches to the development of interdisciplinary programs that offer potential solutions to problems of special significance to the mission of NIH. Support is limited to a maximum of 5 years and is not renewable. Grants are awarded directly to the applicant's institution and are not transferable to another institution. Under this RFA, applicants can request up to $410,000 per year for direct costs, where $10,000 per year should be designated for travel for annual meetings in Washington and for networking visits with other Centers. Although the Facilities and Administrative (F&A) costs associated with all contractual and consortium arrangements are considered as direct costs to the applicant organization, for the purposes of this RFA only, these will not count against the direct cost limits for this RFA. (However, these costs should be indicated as instructed on PHS 398, rev. 5/2001.) FUNDS AVAILABLE NIMH, NIDA, and NIAAA intend to commit up to approximately $2.3 million in FY 2004 to fund up to 3 new grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $410,000 per year. Although the financial plans of the participating ICs provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your domestic institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Faith-based or community-based organizations Foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. The Principal Investigator should be an established independent intervention researcher in the area(s) of mental illness, SUDs and/ or AUDs and will have a minimum time commitment of 30 percent to the Developing Center. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Institutions eligible under this RFA should have both ongoing research activity in suicide prevention, mental disorder and/or SUD and/or AUD prevention or intervention, and a demonstrated need for infrastructure support to take full advantage of their research potential. The existence of research activity is evidenced by the presence of ongoing research funded under PHS grants or equivalent sources of peer-reviewed support, and recent record of peer-reviewed scientific publications. This RFA is intended to support research directly relevant to suicide preventive interventions. Basic research in suicide risk is also of interest to NIMH. Applicants interested in seeking support for a center for basic neuroscience research relevant to mental illnesses should see PAR-02-121, Silvio Conte Centers for Neuroscience Research (http://grants.nih.gov/grants/guide/pa-files/PAR-02-121.html) and those interested in a center for translational research between basic and clinical neuroscience research on severe mental illnesses should consider PAR-02-122, Silvio Conte Centers for the Neuroscience of Mental Disorders (http://grants.nih.gov/grants/guide/pa-files/PAR-02-122.html). Applicants interested in seeking support for a center for research at the interface between basic behavioral research and neuroscience should see PAR-00-130, Interdisciplinary Behavioral Science Centers for Mental Health (http://grants.nih.gov/grants/guide/pa-files/PAR-00-130.html). Applicants interested in a center that would foster research projects on the translation of basic behavioral research to mental disorders and public health applications should consider PAR-01-027, Translational Research Centers in Behavioral Science (http://grants.nih.gov/grants/guide/pa-files/PAR-01-027.html). Under this RFA, $10,000 per year should be designated for travel for one annual meeting in Washington and for additional networking visits with other Centers. Allowable Costs The grant mechanism of this RFA (P20) provides funding for infrastructure and developmental research projects only. Investigators seeking support for specific investigator-initiated research projects should use mechanisms other than the P20 (e.g., R01, R03). Under this RFA, funds can be used to support research participant recruitment for all populations, especially activities to ensure appropriate participation by women, children and adolescents, elderly and other traditionally understudied populations, such as racial and ethnic minorities and people in rural areas. Those developing centers that will conduct intervention trials may request funds to support the establishment of a Data and Safety Monitoring Board for those trials. Funds may also be used for travel, salaries, meeting expenses, subcontracts and paying consultants. Applicants are referred to the General Clinical Research Center program at the NIH/National Center for Research Resources (http://www.ncrr.nih.gov/clinical/cr_gcrc.asp) as a potential resource for inpatient and outpatient facility costs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Jane L. Pearson, Ph.D. Chair, Suicide Research Consortium National Institute of Mental Health 6001 Executive Boulevard, Room 7160, MSC 9635 Bethesda, MD 20892 Telephone: (301) 443-3598 FAX: (301) 594-6784 Email: jp36u@nih.gov Lisa Onken, Ph.D. Division of Treatment Research and Development National Institute on Drug Abuse 6001 Executive Boulevard, Room 4123 MSC 9551 Bethesda, MD 20892-9551 Telephone: (301) 443-2235 Email: Lisa_Onken@nih.gov Charlene E. LeFauve, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Telephone: (301) 402-9401 FAX: (301) 443-8774 Email: clefauve@NIAAA.nih.gov o Direct your questions about peer review issues to: Michael Kozak, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6138, MSC 9608 Bethesda, MD 20892-9608 Rockville, MD 20852-9608 (for express/courier service) Telephone: (301) 443-1340 FAX: (301) 443-4720 Email: kozakm@mail.nih.gov o Direct your questions about financial or grants management matters to: Joy R. Knipple Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-8811 FAX: (301) 443-6885 Email: jknipple@nih.gov Judy Fox Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505 MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 for express/courier service) Telephone: (301) 443-2434 Email: jsimons@niaaa.nih.gov Catherine Mills Grants Management Branch National Institute on Drug Abuse 6001 Executive boulevard, Room, 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: cm108w@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Jane L. Pearson, Ph.D. Chair, Suicide Research Consortium National Institute of Mental Health 6001 Executive Boulevard, Room 7160, MSC 9635 Bethesda, MD 20892 Telephone: (301) 443-3598 FAX: (301) 594-6784 Email: jp36u@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: Applications for this RFA are limited to the following: Introduction and Operations Core: 10 pages; Methods Development Core: 10 pages; Principal Research Core: 12 pages. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Jean G. Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9663 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-3367 FAX: (301) 443-4720 Email: jnoronha@mail.nih.gov APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the participating ICs. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the participating ICs in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this center and its associated research projects address suicidality as an important public health problem? If the aims of the application are achieved, how will scientific knowledge of intervention research be advanced? What will be the effect of the center and its affiliated studies on care in community settings? APPROACH: Is there adequate rationale to support the importance of a center approach as opposed to other mechanisms (e.g., individual R01 applications)? Does a conceptual and theoretical framework focused on a major topic in intervention research inform the center organization and infrastructure development? Is the concept of a center fulfilled, including: (1) an integrated theme bringing together a multidisciplinary team of investigators in a common mission, (2) development of a pooled, core database or access to research participants that can yield results beyond that accomplished with individual projects alone, (3) attraction of established investigators and development of collaboration among investigators with diverse backgrounds and areas of expertise, (4) a research mentorship component for new investigators through research training and career development mechanisms, and (5) a process for stimulation and evaluation of new pilot study proposals? Is the approach for the center adequately developed, well integrated, and appropriate to the general aims of the center? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are collaborations across sites well justified and reasonable to carry out the research activities? INNOVATION: Does the center propose to develop novel concepts, approaches, measures or methods in the development and assessment of interventions? Are the aims original and innovative? Does the center extend existing approaches or develop new methodologies or technologies appropriate to the assessment of interventions? INVESTIGATOR: Are the center director and other senior investigators at the forefront of their respective fields? Do they have the experience and authority necessary to organize, administer and direct the center? ENVIRONMENT: Does the scientific environment of the center contribute to the probability of success? Does the center take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is the center able to gain and sustain access to a representative range of people in a broad set of academic and community settings? Is there evidence of institutional support? Are the collaborating sites chosen for the center the appropriate ones to address the research questions proposed? ADDITIONAL REVIEW CRITERIA: With regard to the developmental research projects proposed, such projects are not expected to be major research proposals where major experimental hypotheses can be tested in a definitive manner. Rather, such projects are intended to provide preliminary data to be utilized in guiding the design of future more definitive investigations. In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 17, 2003 Application Receipt Date: November 18, 2003 Peer Review Date: February 2004 Council Review: May 2004 Earliest Anticipated Start Date: July 1, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). For further consideration of safety and ethical issues specific to suicide intervention research, see http://www.nimh.nih.gov/research/highrisksuicide.cfm. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by he NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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NIH Funding Opportunities and Notices
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